# FDA 483 - Exercore, LLC - September 02, 2021

Source: https://www.globalkeysolutions.net/records/483/exercore-llc/767168d2-54a9-4b5e-a669-2b807b2dbd5d

> FDA 483 for Exercore, LLC on September 02, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Exercore, LLC
- Inspection Date: 2021-09-02
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: Exercore, LLC, a manufacturer in Shakopee, MN, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate procedures for incoming product acceptance and quality audits, insufficient documentation for complaint investigations, and a non-compliant and inaccessible design history file with untranslated foreign language content. These issues indicate a lack of robust quality management practices.

## Related Documents

- [483 - 2018-12-18](https://www.globalkeysolutions.net/records/483/exercore-llc/6fba199a-9503-428a-b15c-04a989f5adba)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.globalkeysolutions.net/companies/exercore-llc/ec79efa9-67bc-4138-ad58-1da076398e9b

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d